Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery

Postoperative Pain Clinical Trial

Official title:

Comparison of Analgesic Efficacy of Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193488
• Other study ID #: 19/342
• Status: Completed
• Phase: N/A
• Start date: October 23, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: February 2020
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ethics committee approval was taken on October 22, 2019, numbered 19/342. 120 adult patients who will undergo spine stabilization surgery between October 2019 and January 2020 in "Gülhane Training and Research Hospital" were planned to be included in the study. Patients will be randomized to 30 patients with MTP block (Group MTP) and ESP block (Group ESP) and no block (Group K) in addition to patient-controlled analgesia (PCA). Postoperative pain scores, analgesic use, number of PCA button presses, total amount of opioid administered and complications due to opioids will be recorded. The obtained data will be compared statistically.

Description:

Ethics committee approval was taken on October 22, 2019, numbered 19/342. 120 adult patients who will undergo spine stabilization surgery between October 2019 and January 2020 in Gulhane Training and Research Hospital were planned to be included in the study. Appropriate patients will be informed about the study and their written consent will be obtained. All patients were scheduled for ASA I-III. Exclusion criteria for patients are as follows: ≤18 or ≥81 years old, body mass index (BMI) ≥30 or ≤18 kg / m2, skin infection where the needle is punctured, allergic drugs to any of the study, pre-existing pain syndromes, pregnancy, severe liver diseases), kidney diseases (serum creatinine greater than 2 mg / dL, oliguria, anuria or hemodialysis) or cardiovascular disorders (functional class of the New York Heart Association greater than III). During the preoperative visit, all patients will be instructed on how to assess their pain using a numerical analogue pain scale (0 = no pain, 10 = maximum pain to be considered) and patient-controlled analgesia (PCA). Patients will be randomized according to a computer-generated random number table, in addition to patient-controlled analgesia (PCA) with MTP block (Group MTP) and ESP block (Group ESP) and no block (Group K). Nerve blocks will be made at the end of the operation after the surgical site is sutured and intact before the dressing is done. The linear ultrasound probe will be applied in the prone position bilaterally in the region of the transverse process corresponding to the center of the incision line by the same three experienced senior doctors with ultrasound guidance covered with sterile probe sheath. In the ESPB group, a high-frequency 15 6 MHz (Megahertz) linear ultrasound probe will be placed vertically about 3 cm laterally from the midpoint of the incision line in the midline. Once the erector spinae muscle and transverse projections have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml normal saline injection, this plane will open. Twenty milliliters of 0.25% bupivacaine will be given for the block. The same procedure will be applied 3 cm later than the incision line. In the MTP Group, a high frequency HFL-50 15-6 MHz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Using the parasaggital scan, the block needle (50 mm 22 Gauge) will be advanced from the caudal to the cervical target of the paravertebral cavity. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml normal saline is performed. Once the needle tip has been confirmed, 20 ml of 0.25% bupivacaine will be given to the block. The same procedure will be applied 3 cm later than the incision line.

No regional plan block will be applied to the control group. All groups will receive analgesia in the postoperative period using patient-controlled analgesia (PCA), and the pain will be evaluated three days postoperatively using a numerical grading scale (NRS) ranging from 0 (painless) to 10 (worst imaginable pain). The number of PCA button presses, the total amount of opioids applied, and complications associated with opioids will be recorded. The obtained data will be compared statistically

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 15, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18-80 years old

• ASA (American Society of Anesthesiologists) score between I-III.

Exclusion Criteria:

• ASA (American Society of Anesthesiologists) score >III,

• emergency surgery,

• secondary surgery,

• receiving chronic pain treatment

Related Conditions & MeSH terms

• Anesthesia, Regional
• Postoperative Pain
• Spinal Stenosis

Intervention

Behavioral:
• MTP block
In the MTP Group, a high frequency HFL-50 15-6 MHz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Using the parasagital scan, the block needle (50 mm 22 Gauge) will be advanced from the caudal to the cervical target of the paravertebral space. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml saline is performed. Once the needle tip has been confirmed, 20 ml of 0.25% bupivacaine will be given to the block. The same procedure will be applied 3 cm later than the incision line.
• ESP block
In the ESP group, a high-frequency 15-6 megahertz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Once the erector spinae muscle and transver projections have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml saline injection, this plane will open. Twenty milliliters of 0.25% bupivacaine will be given for the block. The same procedure will be applied from the other 3 cm lateral of the incision line.
• No Block group
No regional plan block will be applied to the control group. Conventional analgesic methods were applied.

Locations

Country	Name	City	State
Turkey	Gulhane Training and Research Hospital	Ankara	Keçiören

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numeric rating scale (NRS)	Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS) was assessed using three days after surgery	three days postoperatively
Primary	use of patient control analgesia	The number of PCA button presses, the total amount of opioids applied	three days postoperatively
Primary	complications related to opioids	Nausea, Vomiting, Itching, Constipation, Difficulty in urination, Difficulty in Concentration, Drowsiness or difficulty staying awake, Feeling of light dizziness, Feeling of dizziness, Feelings of general fatigue or weakness, Dry mouth, Headache	three days postoperatively
Primary	Additional analgesic use	Additional analgesic dexketoprofen (trometamol) 50 mg / 2 ml will be administered to patients with an NRS score> 3 and the amount of use will be recorded.analgesics	three days postoperatively